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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00521456
Other study ID # 191578-006
Secondary ID
Status Completed
Phase Phase 3
First received August 23, 2007
Last updated September 29, 2009
Start date October 2007
Est. completion date March 2008

Study information

Verified date August 2009
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery


Recruitment information / eligibility

Status Completed
Enrollment 263
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing cataract surgery

Exclusion Criteria:

- Uncontrolled ocular disease in cataract surgery eye

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ketorolac eye drops
1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of Post Operative Inflammation Day 14 No
Secondary Ocular Pain Day 1 No
Secondary Mean Pupil Area Day 0 No
See also
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Completed NCT00565695 - Evaluation of the Aspheric ReSTOR Intraocular Lens (IOL) After Routine Cataract Extraction N/A
Completed NCT00524264 - A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery Phase 3
Completed NCT02973880 - Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Phase 3
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Completed NCT00851760 - Epiretinal Macular Membrane and Cataract Extraction N/A
Recruiting NCT03944070 - Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery N/A
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Completed NCT00824070 - Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects Phase 1
Completed NCT00366587 - Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs Phase 4
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